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EU MDR Labeling Compliance: Learn the Lessons from UDI
EU MDR is being viewed as an extension of the FDA’s UDI (Unique Device Identification), but also a ‘step up’. However, it’s more detailed and more complex due to the local language requirements needed for Europe.
The introduction of UDI requirements into the EU is good news for organizations that are already along the pathway of adopting systems and processes to support FDA UDI compliance. However, for those that aren’t – and indeed those that may have made only basic adjustments to their labeling infrastructure in response to the regulations – there are five key learnings that have emerged from the UDI experience that may help inform best practice adoption with EU MDR.
Join us for this 60-minute information packed webinar to discover why EU MDR will change the medical device labeling landscape globally and how to best meet the impending challenges.
Key Learning Objectives:
- Understand what EU MDR compliance means for your business and how it will affect your labeling processes
- Develop an understanding of the market’s perceptions of EU MDR
- Recognize what the biggest labeling compliance challenges ahead are and how to proactively overcome them
- Embrace the lessons from UDI to work smarter in meeting the implementation deadlines of MDR by May 2020 and IVDR by May 2022
- Learn about a labeling system that can adapt to regulations that will be following for other countries that are not part of the US or EU, so that any new regulation does not have a similar size impact
VP Capability Development
Andrew Love is a multi-award-winning packaging and artwork management strategist, leader and author. Andrew spent 10 years as head of global packaging design operations at GlaxoSmithKline, the world’s second largest pharmaceutical company at the time. During his time there he oversaw the transformation of the global artwork management activities into a world-class, award-winning capability. Andrew is one of the founders of Be4ward which helps pharmaceutical, biotech and other healthcare companies and their supply base to improve patient safety and drive additional value from their product range. He now develops products for, and works with, a number of pharmaceutical and healthcare companies in achieving these aims. Andrew, a professional engineer and MBA with over 20 years of experience, has worked with many of the world’s largest life-sciences companies.
VP Research and Development
Mark Cusworth has over 15 years of experience heading up a team providing off the shelf and tailored solutions to Life Science companies. During this time, he has seen many changes to the industry including significant tightening of regulations and challenges of globalization. His primary objectives are to target the ongoing investment in research, development and quality effectively and to lead the company in-house research and development to maintain the market leading position of PRISYM ID’s world class label management software.
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Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organization design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range. Corporate website: www.be4ward.com Contact: email@example.com